Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI

NCT06275035 | Recruiting Phase 3

• 1 other identifier: 4235
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the role of memantine in preservation of memory and neurocognition in patients undergoing craniospinal irradiation. Participants will be randomised into two arms and the interventional arm will receive memantine along with the standard treatment. Researchers will compare the neurocognitive tests of participants in both the arms to see if memantine leads to significant preservation of memory and cognition post radiation therapy.

Conditions

Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Cognitive-deterioration-free survival at 2 years

  Cognitive-deterioration-free survival at 2 years; defined by a drop of 5 points in any of Full Scale Intelligence Quotient (FSIQ), Verbal Intelligence Quotient (VIQ), or Performance Intelligence Quotient (PIQ) compared to baseline (pre-radiation) on Wechsler Adult Intelligence Scale (WAIS), and Wechsler Intelligence Scale for Children (WISC).

  2 years

Secondary Outcomes (6)

• Full-Scale Intelligence Quotient (FSIQ) in children

  7 years

• Overall survival (OS)

  7 years

• Academic performance by scholastic performance and grades

  7 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Memantine

  2 years

• Progression-Free Survival (PFS)

  7 years

Other Outcomes (3)

• Full Scale Intelligence Quotient change in subgroups

  7 years

• Radiological features of cognitive decline on Magnetic Resonance Imaging

  7 years

• Neuroinflammatory markers correlation with neurocognitive decline and survival

  7 years

Study Arms (2)

Experimental arm

EXPERIMENTAL

Participants in the experimental arm (memantine) will be started on memantine. The starting dose of memantine will be 5mg once daily at bedtime for 1 week, followed by 5mg twice daily for 1 week, and finally increased to the full dose of 10 mg twice daily for 6 months.

Drug: Memantine Oral Tablet

Standard arm

NO INTERVENTION

Participants in the standard arm will continue the standard treatment as planned.

Interventions

Memantine Oral Tablet DRUG

Drug to preserve memory and neurocognitive dysfunction induced by radiation therapy

Also known as: Memantine

Experimental arm

Eligibility Criteria

• Age: 5 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age at irradiation: 5 to 39 years
• Planned for CSI (with or without boost dose) with or without systemic chemotherapy
• Informed consent or assent taken
• Karnofsky Performance Status / Lansky Performance Status ≥ 60

You may not qualify if:

• Re-irradiation
• Prior exposure to memantine
• Inability to undergo Wechsler test

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (2)

• Brown PD, Pugh S, Laack NN, Wefel JS, Khuntia D, Meyers C, Choucair A, Fox S, Suh JH, Roberge D, Kavadi V, Bentzen SM, Mehta MP, Watkins-Bruner D; Radiation Therapy Oncology Group (RTOG). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial. Neuro Oncol. 2013 Oct;15(10):1429-37. doi: 10.1093/neuonc/not114. Epub 2013 Aug 16.

  PMID: 23956241 BACKGROUND

• Brown PD, Gondi V, Pugh S, Tome WA, Wefel JS, Armstrong TS, Bovi JA, Robinson C, Konski A, Khuntia D, Grosshans D, Benzinger TLS, Bruner D, Gilbert MR, Roberge D, Kundapur V, Devisetty K, Shah S, Usuki K, Anderson BM, Stea B, Yoon H, Li J, Laack NN, Kruser TJ, Chmura SJ, Shi W, Deshmukh S, Mehta MP, Kachnic LA; for NRG Oncology. Hippocampal Avoidance During Whole-Brain Radiotherapy Plus Memantine for Patients With Brain Metastases: Phase III Trial NRG Oncology CC001. J Clin Oncol. 2020 Apr 1;38(10):1019-1029. doi: 10.1200/JCO.19.02767. Epub 2020 Feb 14.

  PMID: 32058845 BACKGROUND

MeSH Terms

Conditions

Cognition Disorders

Interventions

Memantine

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Tejpal Gupta, MD

CONTACT

02224177000; drtejpalgupta@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Tejpal Gupta, Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 23, 2024
• Study Start: February 22, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)